MS H was a 43-year-old woman, mother of two young children, and a successful business executive when she was invited by her employer to undergo a “cardiac health assessment” in March 2019.

The assessment consisted of a coronary artery calcium score and CT coronary angiogram.

Ms H had no history of cardiac problems but was encouraged by her workplace to undergo the assessment. Dr T was the radiologist in attendance on the day Ms H attended for the procedures and was the only doctor on site. Unfortunately, Ms H had a severe allergic reaction when the Omnipaque dye was administered intravenously. Resuscitation was commenced at the radiology practice, an ambulance called and Ms H was taken to hospital, but she died about a week later without regaining consciousness.

The cause of death was multisystem organ failure and hypoxic/ischaemic encephalopathy due to anaphylactic reaction to computed tomography (CT) contrast medium.

The scan report showed that Ms H had a calcium score of 0 and normal coronary angiogram.

Ms H’s death was the subject of a coronial inquest. Ms H’s family requested an inquest, noting that a number of factual issues required investigation and that there were important public health implications, “including the process of company employees being tested, the failure to be seen by a doctor prior to an invasive test and the management of [her] anaphylactic reaction”.

Inquest outcome

The inquest lasted over two weeks, involving 16 witnesses, and six expert witnesses.

The coroner found that the impetus for the “cardiac health assessment” program had arisen from the best of intentions after a worker for Ms H’s employer had suffered, but survived, a cardiac arrest. Following this, the managing director wanted to give his staff the opportunity to have “the best private medical assessment program for heart health” at the company’s cost, and he asked one of his managers to develop a suitable program.

The coroner investigated the complex arrangements of business entities and individuals involved in the development and implementation of the “cardiac health assessment” program.

The coroner determined that Ms H died as a result of substandard clinical judgement from doctors at the beginning and end of this program, combined with a misalignment of incentives among the various business entities that facilitated the process. The inquest heard evidence about an industry putting profits over patients.

The “cardiac health assessment” program had been developed without obtaining formal and considered medical advice on the risks of the tests, or whether these two tests were the most suitable or whether there should have been a preliminary assessment by a medical practitioner.

The radiology request forms were affixed with Dr S’s electronic signature, although he had never seen or spoken to the people undergoing the tests, and he considered his role was to receive the results and have a discussion with the participants about their results.

The coroner considered that Ms H had not fully given her consent as she did not know the true nature of the procedure, and possible alternate pathways, and had not discussed the procedures with either the referring doctor or the radiologist.

Ahpra notifications

The referring doctor, Dr S, was referred to Ahpra. The coroner was critical that Dr S had allowed his signature to be used for referrals for patients he had not reviewed, and that Dr S failed to apply ethical standards as he considered himself to hold a lesser obligation to persons who he considered to be “clients” or “candidates” rather than “patients”.

The radiologist, Dr T, was also referred to Ahpra, with the coroner finding that the CT scan was performed on the basis of a referral with insufficient clinical detail, and that Dr T failed to recognise and manage Ms H’s anaphylaxis appropriately.

Recommendations

Extensive recommendations were made by the coroner, with many relating to improving the recognition and management of severe contrast reactions and anaphylaxis.

Other recommendations include that:

  • the Royal Australian and New Zealand College of Radiologists (RANZCR) prepare a joint position statement with the Cardiac Society of Australia and New Zealand regarding when screening is an acceptable indicator for a CT angiogram or other invasive cardiac tests;
  • RANZCR update its standards and guidelines regarding both clinical requests and consent procedures to address the increasing prevalence of screening requests, and to ensure that imaging procedures are not performed for screening when lower risk alternatives might achieve the same end; and
  • the Royal Australian College of General Practitioners and the Australasian Faculty of Occupational and Environmental Medicine prepare a joint position statement on the appropriateness of a practitioner authorising, or otherwise allowing, their signature to be used in referring individuals (whether patients, clients or candidates) for tests when neither the patient nor any information specific to the patient has been reviewed.

Dr Jane Deacon is the Manager or Medico-Legal Advisory Services at MDA National.

This article is provided by MDA National. They recommend that you contact your indemnity provider if you need specific advice in relation to your insurance policy or medico-legal matters. Members can contact MDA National for specific advice on freecall 1800 011 255 or use the “contact us” form at mdanational.com.au.

 

 

6 thoughts on “Caution advised over heart screening tests

  1. Dr Greg Mewett says:

    An absolute effing tragedy that should never have occurred.
    She was my daughter’s age so that hits home to me!

    I agree totally with the comments about the appalling lack of ethical and clinical behaviour in all of this. A money-making exercise with little care or responsibility, it seems.
    That’s why we have Ahpra and the Coroner!

  2. Randal Williams says:

    The point about non medical recommendation for screening tests is a valid one. It is now common for public figures/celebrities who have had some type of medical event or cancer to exhort the public “go and get tested”. This is not only alarmist but also can result in inappropriate or over-use of tests and services, and the potential for iatrogenic problems from medical interventions that ultimately might prove unnecessary.

  3. Anonymous says:

    AS a radiologist I am extremely concerned about this scenario. I could understand that a “cardiac health test” might involve symptom & FH review, Se cholesterol, RBS, etc., BP, perhaps chemical urinalysis, maybe the calcium score, BUT not a CTCA, especially in a patient who has not been seen/assessed by the referrer.

    There is a radiation dose (particularly to the breast) and the risk of contrast reaction, though less common than with the old ionic agents, is not negligible.
    In normal radiological practice, informed consent is required. At a minimum, it is usual for the radiologist to be required (attached to his/her signature) to state that the procedure and radiation exposure are clinically appropriate.
    “Screening” or no clinical notes on a request for an invasive procedure is not acceptable.
    For anyone to allow their signature to be used in this fashion is not ethical, nor is it good clinical practice.

    It was a wise decision by the coronary to request policy review etc in this instance.

  4. Anonymous says:

    I have generally negative opinions about the use of Calcium Scores and even more so about CTCA as health assessment without clinical indication, and am not an orphan in these respects. My main comment, however, is more general, and a reaction to the Anonymous thought yesterday at 1:25 PM: ” I cannot see that the radiologist had any right to not accept the referral from a registered practitioner.”
    I believe that the doctor who regards a Request for a Radiological Examination as an Order is arrogant, and that the Radiologist who accepts the Request as an Order is copping out from his/her responsibility to the patient. The patient is not in a position to make a knowledgeable judgment and is thereby potentially subject to various kinds of abuse, specifically emotional, physical and financial.

  5. Sue Ieraci says:

    It’s so important that we see evidence of harm from excessive investigation. As a profession, we are always criticising each other for (allegedly) “missing something” when we should be just as much aware of the harms of over-diagnosis. Thank you for a sobering article.

  6. Anonymous says:

    I think the real problem here is that a non medical person( the empolyer) ,however well motivated,was the driving force behind the performing of the scan. The employee may have felt it wise not to appear ungrateful to her employer ,again likely well motivated,invitation.Had the 43 year old woman who had the anaphylaxis gone through non private channels to seek a cvs risk assessment it is highly unlikely that without compelling risk factors ,a CTCA would have been advised. A coronary calcium score may have been requested as it is considered to be,by many experts,the most accurate way of calculating cvs risk in an asymptomatic person. In fact there may have been grouds for complaint if one was not at least discussed at a cvs risk review consult and a preventable cvs event later be encountered. I cannot see that the radiologist had any right to not accept the referral from a registered practitioner. They would of course have been unable to bill medicare without the referral fulfilling the appropriate criteria.
    Had she survived the anaphylaxis she may well have had grounds to claim she had not been informed of the risk of such an event..

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